Medical Device & Diagnostic Industry

January 1999 MD&DI
Selected Contents

COVER STORY:
Process Considerations in the Extrusion of Microbore Tubing
by Hans W. Kramer

Successful processing of small-diameter medical tubing requires careful control over a multitude of variables.

SPECIAL SECTION:
Conductive Plastics for Medical Applications
by Larry Rupprecht and Connie Hawkinson

Polymer materials compounded with a variety of additives provide design flexibility in protecting against static accumulation, ESD, and EMI/RFI.

SECTION 207:
Section 207: Is Your Class III Designation Really Final?
by H. Neal Dunning and Timothy R. Littlefield

Also known as "de novo," section 207 of FDAMA allows certain low-risk medical devices to be reclassified into Class I or Class II, thereby avoiding costly PMAs.

PACKAGING:
New Methods to Assess the Performance of Prototype Form-Fill-Seal Packages
by A. Brent Strong and Thomas E. Blair

A study describes novel test procedures and equipment to detect packaging problems early in the development process.

SOFTWARE RISK MANAGEMENT:
Software Risk Management for Medical Devices
by Bill J. Wood

As more devices integrate software, early risk management is critical to ensure that the devices are trustworthy.

OUTCOMES RESEARCH:
Outcomes Research: Documenting the Value of a Medical Device
by Bryan R. Luce and Anne Elixhauser

Evidence gathered from outcomes research conducted from the beginning of product development can help convince purchasers and end-users of a device's economic value, regardless of its cost, and give manufacturers a competitive edge.

MOTION CONTROL:
Choosing Motion Control Components
by Michael Backman

Designers of motion control systems today must choose from among an ever-expanding array of components and technologies.

COMBINATION DEVICES:
Device and Biologic Combination Products: Understanding the Evolving Regulation
by Sharon A. Segal

FDA is establishing new policies and guidelines to deal with combination device and biologic products. Manufacturers must keep abreast of the latest developments to avoid costly delays.

ISO 10993:
A Practical Guide to ISO 10993-3: Carcinogenicity
by Paul J. Upman and Richard F. Wallin

This final installment in MD&DI's series of articles on the international biocompatibility standards discusses when and how to conduct carcinogenicity testing.

DESIGN OF EXPERIMENTS:
Design of Experiments for Process Validation
by Mark J. Anderson and Paul J. Anderson

Used as one of the statistical tools for validation, design of experiments can help identify which factors need to be controlled in order for a system or product to pass the ruggedness test.

INSIDE MD&DI:
Making Device Software Truly Trustworthy
Sherrie Steward

FIRST PERSON:
FDAMA: One Year Later
An anniversary review of the legislation
by James S. Benson

A year after the FDA Modernization Act was signed into law, a top HIMA official assesses the benefits of the new provisions and raises ongoing concerns regarding future implementation.

WASHINGTON WRAP-UP:
Year-End Report Notes Faster Reviews, More Changes at FDA
by James G. Dickinson

Also:

• Device Interaction Alert
  
• Henney Confirmation
  
• PMA "Not Approvable"
  
• Balloon Stent Alert
  
• FDA One-Sidedness Continues
  
• MRA Transition Delayed
  
• CDRH Draft Inspection Handbook

R&D HORIZONS:
Digital Imaging Heralds Waning of Film Era
by Greg Freiherr

Advances in digital detectors drive the evolution of radiography.

BOTTOM LINE:
Avoiding Gaps in Clinical Trials Liability Insurance
by Glen B. Carlson

When companies test high-risk procedures or devices, the potential for costly liability claims skyrockets. Having the right liability insurance can be vital to a company's success.

HELP DESK:
CE Marks/IVD Directive, Computer Issues, and Complaint-Rate Data versus Risk Analysis

Three industry experts answer questions concerning the use of the CE mark, validation of computer chips, risk analysis, and other manufacturing concerns.

EMI FIELD NOTES:
Choosing Conducting Material Interfaces for Seams and Joints
by Richard Haynes

Selecting proper materials minimizes corrosion EMC problems.

SNAPSHOT:
Joining the Game: Orthopedist Brings Science, Strategy to Device R&D
by Kassandra S. Kania

EDITOR'S PAGE:
The Voice From The Top: Henney's "Recall" Signals A New Era at FDA
by John Katz

Jane Henney begins her term as the new FDA commissioner by restating her commitment to ongoing agency reforms.